BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 21900636 · Received April 24, 2025

    Report

    Report Number
    1220246-2025-01702
    Event Type
    Injury
    Date Received
    April 24, 2025
    Date of Event
    August 21, 2024
    Report Date
    April 24, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED UNKNOWN SCREW WAS RECEIVED FOR INVESTIGATION ALONG WITH THE COMPLAINT DEVICE FOR (B)(4) (AN AR-2655CL BATCH NUMBER: 5262149). VISUAL EVALUATION OF THE RETURNED DEVICE NOTED NO ISSUES WITH THE DEVICE. NO DAMAGE WAS OBSERVED TO THE THREADS. FUNCTIONAL TESTING WAS NOT ABLE TO BE PERFORMED DUE TO THE DAMAGE OF THE MATING AR-2655CL AND DIMENSIONAL TESTING COULD NOT BE PERFORMED DUE TO NO PART NUMBER IDENTIFIER BEING PROVIDED OR VISIBLE ON THE SCREW. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT. REFER TO INVESTIGATION PHOTOS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A COLLARBONE / CLAVICLE SURGERY THERE WAS A MATERIAL FRACTURE AND THE CLAVICLE PLATE BROKE DURING SURGERY. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (PLATE FROM ANOTHER MANUFACTURER). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 13-FEB-2025: THIS LINE WAS CREATED FOR ONE OF THE SIX SCREWS, WHICH WERE RETURNED WITH THE REPORTED PLATE. THERE IS NO FAILURE REPORTED FOR THE SCREWS. UPDATE AVOE 09-APR-2025: FURTHER INFORMATION WAS REQUESTED FROM THE CUSTOMER, TO CONFIRM A PLATE BREAKAGE DURING THE SURGERY AND A NEW CONTACT FROM THE OR MANAGEMENT PROVIDED DIFFERENT INFORMATION THAN THE PREVIOUS CONTACT. ACCORDING TO THE OR MANAGEMENT THE CLAVICLE PLATE DID NOT BREAK DURING THE SURGERY, BUT THE BREAKAGE OF THE PLATE OCCURRED AFTER THE SURGERY AND AFTER THE PATIENT WAS DISCHARGED. A REVISION SURGERY WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476575 UNK BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other